[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56707-56708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se05-140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0210]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
28, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, inlcuding first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension
With the passage of the Animal Drug Availability Act (ADAA),
Congress enacted legislation establishing a new class of restricted
feed use drugs called Veterinary Feed Directive, which can be
distributed without involving State pharmacy laws. Although controls on
the distribution and use of VFD drugs are similar to those for
prescription drugs regulated under section 503(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD
regulation under 21 CFR 558.6 is tailored to the unique circumstances
relating to the distribution of medicated feeds. The content of the VFD
is spelled out in the regulation. All distributors of medicated feeds
containing VFD drugs must notify FDA of their intent to distribute, and
records must be maintained of the distribution of all medicated feeds
containing VFD drugs. The VFD regulation ensures the protection of
public health while enabling animal producers to obtain and use needed
drugs as efficiently and cost-effectively as possible.
[[Page 56708]]
In the Federal Register of June 10, 2005 (70 FR 33907), FDA
published a 60-day notice soliciting comments on this collection of
information. In response to this notice, no comments were received.
The respondents for VFD drugs are Veterinarians, distributors of
animal feeds containing VFD drugs, and clients utilizing medicated
feeds containing VFD drugs.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per
21 CFR Section No. of Respondents Response Total Annual Responses Hours per Response Total Hours
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558.6(a)(3) through 558.6(a)(5) 15,000 25 375,000 0.25 93,750
558.6(d)(1)(i) through 558.6(d)(1)(iii) 1,500 1 500 0.25 125
558.6(d)(1)(iv) 20 1 20 0.25 5
558.6(d)(2) 1,000 5 5,000 0.25 1,250
514.1(b)(9) 1 1 1 3.00 3
Total Hours .................... .................... ......................... .................... 95,133
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\1\There are no capital costs or operating and maintenance cost associated with this collection of information
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per
21 CFR No. of Recordkeepers Recordkeeper Total Annual Records Hours per Record Total Hours
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558.6(c)(1) through 558.6(c)(4) 112,500 10 1,125,000 .0167 18,788
558.6(e)(1) through 558.6(e)(3) 5,000 75 375,000 .0167 6,263
Total Hours .................... .................... .................... .................... 25,051
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\1\There are no capitals cost or operating and maintenance cost associated with this collection of information.
The estimate of the times required for record preparation and
maintenance is based on agency communication with industry. Other
information needed to calculate the total burden hours are derived from
agency records and experience.
Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19393 Filed 9-27-05; 8:45 am]
BILLING CODE 4160-01-S